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EC number: 204-465-2
CAS number: 121-33-5
Thirty seven studies of
validity 2 (published data and reports) were reported. Negative results
were obtained in Ames tests.
Negative in gene
mutations and chromosomal aberrations with and without metabolic
Thirty seven studies of
validity 2 (published data and reports) were reported in different
endpoint study records. Some of them concern in vitro mutation studies
in bacteria or mammalian cells, other concern chromosomal aberration
studies, with and without metabolic activation system.
mutations, the study report ofHazleton(1991)
was selected as key study. This study was conducted according to OECD
471 guideline. The study report of Marzin (1979), as well as published
data from Mortelmans (1988), Pool (1982), Ishidate (1984) and Kasamaki
(1982) were selected as supporting studies. All these studies were
performed with acceptable scientific principles and support the negative
results obtained with the key study.
aberrations, the study report ofHazleton(1991)
was chosen as key study. The study followed the OECD 473 guideline and
Other studies reported
deal with the antimutagenic effect of Vanillin in gene mutations (Ohta
1986, Watanabe 1988, Sasaki 1987, De Flora 1994), in chromosomal
aberrations (Sasaki 1990, Keshava 1997, Tamai 1992) or in micronucleus
in vitro on CHO or CHL cells (Keshava 1998). These studies were well
conducted and had the validity 2 or 3 according to Klimish.
Ambiguous and some
positive results observed in published data were not considered valid
because they were not conducted according to recognized guidelines, or
were not enough described for assessment. Data concerned sister
chromatid exchange and micronucleus in vitro.
GENOTOXICITY IN VITRO: negative in gene mutations and chromosomal
aberrations with and without metabolic activation system.
One study concerning
Vanillin with validity 2 was available and was selected as key study.
The summary of this study is the following:
In a OF1 mouse bone
marrow micronucleus assay (Marzin, 1979), 10 females per dose were
treated by gavage with Vanillin (pure) at doses of 500 and 1000 mg/kg
bw. Bone marrow cells were harvested at
6and 30 hours post-treatment. The
vehicle was arachid oil.
The positive control
induced the appropriate response.
signs of toxicity during the study.
Four studies on the
antimutagenic effect with validity 2, were available and were well
described. All of these studies demonstrated that Vanillin had an
GENOTOXICITY: the in vitro genotoxic studies available
indicated negative effects in gene mutations and chromosomal aberrations
with and without metabolic activation system. The in vivo studies
available on micronucleus assay and antimutagenic effect confirm the
absence of genotoxic effect of Vanillin.
All the results
available indicated that Vanillin had no effect in genotoxicity
to classification criteria of EC regulation 1272/2008 Vanillin should
not be classified for genotoxicity.
Short description of key information:
Vanilline showed negative results in in-vitro studies (Ames test,
chromosomal aberrations) and in in-vivo studies.
Endpoint Conclusion: No adverse effect observed (negative)
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